AstraZeneca’s Evusheld (tixagevimab and cilgavimab) has not been recommended by the National Institute for Health and Care Excellence (NICE) for the prevention of COVID-19 in vulnerable adults, the agency said.

In new draft guidance, NICE explained that there is not enough evidence of Evusheld’s effectiveness against current SARS-CoV-2 variants in the UK and those likely to be circulating in the next six months.

This reflects a decision made in January by the US Food and Drug Administration to withdraw its emergency use authorisation for Evusheld as a preventative treatment for COVID-19, also citing insufficient evidence of the drug’s ability to protect against dominant variants.

Evusheld contains two antibodies that boost protection against COVID-19 for those who are unlikely to have an adequate immune response to vaccination, or who cannot be vaccinated.

In developing the guidance, the agency’s independent appraisal committee noted that the only evidence demonstrating any clinical benefit for Evusheld was from a trial completed earlier in the pandemic when different variants of the COVID-19 virus were circulating.

The drug did show some effectiveness against some older Omicron variants in in vitro studies, NICE said, but the studies ‘showed clearly’ that it did not protect against the current common and fastest growing variants.

Merck – known as MSD outside the US and Canada – has reported that its COVID-19 drug, jointly developed with Ridgeback, did not significantly reduce the risk of infections in those living with someone recently diagnosed with the virus.

Lagevrio (molnupiravir) is already authorised to treat certain adults who have been diagnosed with COVID-19 in several markets, including the US, UK and China, but is not authorised anywhere for the prevention of the virus.

The phase 3 MOVe-AHEAD trial evaluated the safety and efficacy of Lagevrio compared to placebo in preventing the spread of SARS-CoV-2 within households.

The trial enrolled over 1,500 participants who were randomised to receive either the drug or placebo orally every 12 hours for five days.

Those treated with Lagevrio were 23.6% less likely to develop COVID-19 than those given a placebo until day 14, failing to meet the primary endpoint of the trial.

The safety profile of Lagevrio was generally consistent with that observed in previously reported clinical studies and post-authorisation experience in the treatment of COVID-19.

Lagevrio was originally authorised for emergency use in December 2021 by the US Food and Drug Administration, which recently removed the need for a positive test in a bid to increase access to the drug.

The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending three COVID-19 treatments for those at the highest risk of developing severe disease.

The agency’s latest guidance recommends the use of Pfizer’s Paxlovid, GSK’s Xevudy and Roche’s RoActemra.

Paxlovid has been recommended for adults who do not need supplemental oxygen for COVID-19 and are at an increased risk for progression to severe disease, while Xevudy is recommended for the same group in cases where Paxlovid is contraindicated or unsuitable.

RoActemra is recommended for adults who are having systemic corticosteroids and need supplemental oxygen or mechanical ventilation.

Although the majority of the clinical evidence that is available for NICE to review is based on studies done before the emergence of the Omicron variant, the three treatments are recommended because they have shown promise in treating COVID-19 and are also cost-effective.

In the same statement, the agency outlined that it is currently developing a new review process to update its recommendations on COVID-19 treatments so they can be made available to patients at a faster rate if they demonstrate the potential to protect against new variants and are found to be cost-effective.

US-based Eiger BioPharmaceuticals’ investigational agent, peginterferon lambda (Lambda), significantly reduces the number of clinical events in COVID-19 patients with mild to moderate cases, according to new phase 3 data published in the New England Journal of Medicine.

The TOGETHER study, which evaluated newly diagnosed outpatients considered to be at a higher risk, demonstrated a 51% reduction in COVID-19-related hospitalisations or emergency room visits greater than six hours for those receiving a single dose of Lambda compared to placebo.

The effects were consistent across dominant variants and vaccination status, but the treatment effect for Lambda was more pronounced in patients who were treated within three days of symptom onset.

Among individuals with a high viral level at baseline, Lambda resulted in lower viral loads and a higher percentage of patients clearing SARS-Cov-2 RNA by day seven, compared to placebo.

The study included multiple COVID-19 variants of concern and was among the first trials to include a predominantly vaccinated population, with 84% of patients having received vaccination prior to entry.

The new data follows positive top line safety and efficacy results, announced in March 2022 showing that Lambda reduced the risk of COVID-19-related hospitalisations or emergency room visits greater than six hours by 50% and death by 60%.

The collaboration agreement between GSK and Vir Biotechnology (Vir) has been amended, with Vir now continuing to advance new antibodies and vaccines for COVID-19 alone or with other partners.

The companies will continue to work together on their SARS-CoV-2-targeting antibody, sotrovimab, in markets where it is authorised, as well as their experimental COVID-19 antibody, VIR-7832, and a portfolio of other therapies for respiratory diseases such as influenza.

Originally agreed in April 2020, the collaboration saw the partners use Vir’s monoclonal antibody platform technology to accelerate research of existing antiviral antibodies and identify new antiviral antibodies that could be developed as therapeutic or preventive options for COVID-19.

This was expanded in 2021 to include the research and development of new therapies for influenza and other respiratory viruses.

Under the terms of the amended agreement, Vir retains the sole rights to advance solutions arising from the collaborative COVID-19 vaccine and antibody programmes, subject to tiered royalties to GSK.

As well as its COVID-19 programmes, Vir’s development pipeline consists of candidates targeting hepatitis B and D viruses, influenza A and HIV.

The company said in October 2022 that it had been awarded a multi-year contract by the US government to support pandemic preparedness for influenza and other infectious disease threats.